MedicalCV Announces Completion of First U.S. Clinical Case Using AtriLaze(TM) Surgical Ablation System in Open-Heart Surgery
24 Januar 2005 - 3:58PM
PR Newswire (US)
MedicalCV Announces Completion of First U.S. Clinical Case Using
AtriLaze(TM) Surgical Ablation System in Open-Heart Surgery The
Laser System Precisely Replicated Maze Lesions MINNEAPOLIS, Jan. 24
/PRNewswire-FirstCall/ -- MedicalCV, Inc. (OTC:MDCV) (BULLETIN
BOARD: MDCV) , http://www.medcvinc.com/ , a cardiovascular surgery
device manufacturer, focusing on surgical needs surrounding atrial
fibrillation, announced today the completion of the first U.S.
human clinical case using the AtriLaze(TM) Surgical Ablation
System. The diode laser system allows the cardiovascular surgeon to
deliver laser energy to atrial tissue creating exact and complete
lines of cardiac tissue ablation. Dr. Carmelo Otero, Cardiothoracic
and Vascular Surgeon, performed the first U.S. clinical case at
Christus Santa Rosa Hospital in San Antonio, Texas. The 53 year
old, female patient presented with paroxysmal atrial fibrillation
(A-Fib), mitral and tricuspid valve and coronary artery disease.
The AtriLaze(TM) surgical ablation procedure was performed as a
concomitant procedure with mitral valve replacement and tricuspid
valve repair. Use of the AtriLaze(TM) system added a minimal amount
of time to the overall surgical procedure. "The AtriLaze(TM) system
performed well, allowing me to easily and precisely replicate Maze
lesions," said Dr. Otero. "The laser technology provides me the
capability to safely and quickly create an array of cardiac lesions
that enabled today's successful clinical case. The AtriLaze(TM)
system facilitates a simple, reproducible technique that I believe
will be very effective in concomitant cardiac surgical procedures
and potentially lends itself to minimally invasive and robotic
surgical treatments of A-Fib," commented Dr. Otero. Marc P. Flores,
President and Chief Executive Officer of MedicalCV, Inc. commented,
"We are pleased to enter the U.S. market with this innovative
technology for surgical cardiac tissue ablation. The atrial
fibrillation market is in a state of chaos looking for an 'ideal'
technological solution to provide a minimally invasive surgical
option that mirrors outcomes of the 'gold standard' surgical Maze
procedure. This successful surgery represents a further milestone
in the Company's goal of providing a better treatment solution for
ablating cardiac tissue." MedicalCV, Inc. acquired rights to the
AtriLaze(TM) Surgical Ablation System in September 2003 and
received FDA 510(k) clearance on November 30, 2004. The Company is
currently marketing the AtriLaze(TM) system for clinical use and is
focusing its resources on the minimally invasive treatment of A-Fib
as a stand-alone procedure. "The laser's physical properties are a
specific balance of absorption and transmission through atrial
tissue that optimizes overall photocoagulation," said Adam L.
Berman, Vice President, Research and Development. "Through our
continued development efforts, we believe the delivery of light
energy through low-profile fiberoptic elements has the potential to
enable closed-chest, beating heart procedures for cardiac tissue
ablation." About MedicalCV, Inc. MedicalCV, a cardiovascular
surgery device manufacturer, focuses on the design, development and
commercialization of new, improved and enhanced technologies,
products, methods and techniques to treat cardiovascular disorders
and disease, including products targeting the treatment of atrial
fibrillation. Historically, MedicalCV developed and marketed
Omnicarbon(R) mechanical heart valves and its proprietary pyrolytic
carbon processes. The Company acknowledges their continued
maintenance of the mechanical heart valve business, supporting
their customers and distributors during the divestiture process.
The Company also continues to concentrate it resources on the A-Fib
market. The Company's securities are traded on the OTC Bulletin
Board under the symbol "MDCV." For further information on
MedicalCV, Inc., please visit http://www.medcvinc.com/ . You may
register to receive MedicalCV's future press releases and to be
added to the Company's distribution list by visiting:
http://www.roiny.com/form.php . This release contains certain
forward-looking statements of expected future developments, as
defined in the Private Securities Litigation Reform Act of 1995.
The forward-looking statements in this release refer to our
expectations regarding disposition of our heart valve business,
operating improvements, development of atrial fibrillation product
and minimally invasive treatment of atrial fibrillation. These
forward-looking statements reflect management's expectations and
are based on currently available data; however, actual results are
subject to future risks and uncertainties, which could materially
affect actual performance. Risks and uncertainties that could
affect such performance include, but are not limited to, the
following: the Company's ability to fund significant capital needs;
market acceptance in the U.S. of the Company's cardiovascular
products; acceptance, efficaciousness and safety of minimally
invasive techniques for the reduction of atrial fibrillation
through ablation; potential reductions in pricing by competitors;
the costs of licensing and acquiring new products and technologies;
the time and costs involved in obtaining regulatory clearance for
cardiovascular products; competing technological and market
developments; physician acceptance of the Company's cardiovascular
products; dependence upon governmental reimbursements and third
party supplies; and the strength of the market for cardiovascular
products. For more detailed information about these risks and
uncertainties, please review the Company's Annual Report on Form
10- KSB for the fiscal year ended April 30, 2004, and the Form 8-K
filed January 6, 2005. These events and uncertainties are difficult
or impossible to predict accurately and many are beyond the
Company's control. The Company assumes no obligation to publicly
release the results of any revisions that may be made to any
forward-looking statements to reflect events or uncertainties after
the date of such statements or to reflect the occurrence of
anticipated or unanticipated events. DATASOURCE: MedicalCV, Inc.
CONTACT: John H. Jungbauer, Vice President, Finance and CFO of
MedicalCV, Inc., +1-651-452-3000, , or Investor Relations, Robert
Giordano, President, +1-212-495-0200, ext. 10, , or Sarah Shepard,
Vice President, +1-212-495-0200, ext. 17, , both of ROI Group
Associates, Inc. Web site: http://www.medcvinc.com/
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